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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030355
Receipt No. R000034645
Scientific Title Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes. Randomized, open label pilot study.
Date of disclosure of the study information 2017/12/15
Last modified on 2020/11/27

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Basic information
Public title Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes. Randomized, open label pilot study.
Acronym Effect of tofogliflozin and pioglitazone on hepatic steatosis in NAFLD patients with type 2 diabetes.
Scientific Title Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes. Randomized, open label pilot study.
Scientific Title:Acronym Effect of tofogliflozin and pioglitazone on hepatic steatosis in NAFLD patients with type 2 diabetes.
Region
Japan

Condition
Condition Non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effect of tofogliflozin and pioglitazone on liver fat content as measured by using magnetic resonance imaging (MRI) in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change in liver fat content as measured by MRI-based proton density fat fraction (PDFF). <Time Frame: 24 weeks>
Key secondary outcomes <Important secondary outcome>Change in serum ALT level. <Time Frame: 24 weeks>

<other secondary outcomes>
<1>
Secondary outcomes during randomization phase (mono-therapy), <Time Frame: 0 to 24 weeks >;
% change in liver fat by MRI-PDFF., >=10%, >=20% and >=30% reduction of MRI-PDFF., change in liver stiffness by MR elastography., >=5%, >=10% and >=15% reduction of liver stiffness., change in HbA1c, glucose, insulin, and HOMA-R., change in body weight and BMI., change in ALT, AST, gamma-GTP, ALP, total bilirubin and ALT/AST ratio., the proportion of normalization of ALT and AST level., platelet count, total protein albumin and choline esterase and ferritin., type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, and urinary 8-OHdG., number(%) of adverse event.
<2>
Secondary outcomes during combination therapy phase <Time Frame: 24 to 48weeks>; liver fat content, liver stiffness, HbA1c, glucose, insulin, HOMA-R., body weight, BMI, ALT, AST, gamma-GTP, ALP, total bilirubin, ALT/AST ratio., the proportion of normalization of ALT and AST level, platelet count, total protein albumin and choline esterase, ferritin, type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, urinary 8-OHdG., number(%) of adverse event.


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tofogliflozin 20mg <Time Frame: 0 to 24 weeks> , Tofogliflozin 20mg + Pioglitazone 15-30mg <Time Frame: 24 to 48 weeks>
Interventions/Control_2 Pioglitazone 15-30mg <Time Frame: 0 to 24 weeks>, Tofoglifozin 20mg + Pioglitazone 15-30mg <Time Frame: 24 to 48 weeks>
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria <1>Inclusion criteria for study entry;
1. men and women, aged 20-74 years.
2. Type 2 diabetic patients who have been treated with diet/exercise therapy.
3. HbA1c higher than 6.5% (measured within 90 days before study registration).
4. Clinically diagnosed NAFLD
5. ALT higher than the upper limited normal (measured within 90 days before study registration).
6. Patients who provide written consent to participate in the trial of their own free will.
<2>Inclusion criteria for randomization;
Patients with screening MRI-PDFF >= 10% steatosis.
Key exclusion criteria 1. Alcohol consumption greater than 30g/day ethanol for males or 20g/day ethanol for females.
2. Patients diagnosed viral hepatitis.
3. Other causes of liver disease including autoimmune and drug -induced hepatic injury.
4. Patients diagnosed hepatic cirrhosis or serious hepatic dysfunction (Child-Pugh B and C).
5. Platelet count < 150,000/mm3 (measured within 90 days before study registration).
6. BMI < 22 kg/m2 (measured within 90 days before study registration).
7. ALT >= 5 times higher than the upper limited normal (measured within 90 days before study registration)
8. Serious renal dysfunction or eGFR < 60 mL /min/1.73 m2 (measured within 90 days before study registration).
9. Type 1 diabetes or HbA1c >= 9.0% (measured within 90 days before study registration)
10. Patients using SGLT2 inhibitors, pioglitazone, insulin or GLP-1 agonists.
11. Patients taking vitamin E.
12. Contraindications to the MRI (for example, patients using heart pacemaker).
13. Patients who can not undergo MRI (for example, patients who can not hold breath long enough or patients with iron overload).
14. Heart failure (NYHA III or more)
15. Patients with cancer or history of cancer in previous 5 years.
16. Severe ketosis, diabetic coma or precoma.
17. Sever infection, within one week before or after the surgery, sever injury.
18. History of hypersensitivity to any of the ingredients of the study drug.
19. Pregnant women, women suspected of being pregnant.
20. Lactating women or patients who can not prevent conception during study period.
21. Patients who are ineligible in the opinion of the investigator.

Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Yoneda
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa, Japan
TEL 045-787-2640
Email yoneda-ycu@umin.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Yoneda
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 236004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa, Japan
TEL 045-787-2640
Homepage URL
Email yoneda-ycu@umin.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Kowa company ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City Hospital IRB
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
Tel 0453707627
Email rinri@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 10 Month 19 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 11 Month 27 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2020 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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